Press Release

HHS, USDA Establish New Regulations for Use of Select
Biological Agents

The U.S. Departments of Health and Human Services (HHS) and Agriculture
(USDA) today established new safeguards for the possession, use, and
transfer of select biological agents and toxins (select agents) that could
pose a threat to public, animal and plant health and safety.

In complementary regulations announced today, HHS and USDA established
new, tighter controls on these potentially dangerous agents. The regulations
outline the safety and security requirements for possessing select
biological agents and toxins and specify who should be restricted from
working with select agents.

The HHS interim rule updates the previous select agent rule by requiring
facilities to register with HHS' Centers for Disease Control and Prevention
(CDC) if they possess a select agent or agents that pose a potential
threat to human health. The previous rule only required facilities to
register with CDC if they intended to transfer a select agent.

"Protecting the health of Americans is paramount, and this new rule
strengthens our ability to ensure that essential research on these agents
continues while making certain they don't fall into the wrong hands," said
HHS Secretary Tommy G. Thompson.

Similarly, the USDA interim select agent rule requires facilities to
register with USDA's Animal and Plant Health Inspection Service (APHIS) if
they possess a select agent or agents that pose a potential threat to animal
or plant health.

"This new rule will continue to strengthen programs aimed at protecting
the American people from acts of terrorism," said Agriculture Secretary Ann
M. Veneman. "These safeguards will help protect the food supply without
sacrificing valuable research being done on these agents."

Some of the select agents subject to these regulations appear on both the
HHS and the USDA select agent lists. To reduce the burden on facilities
required to register select agents in their possession that overlap both
lists, HHS and USDA have worked together to establish a single unified
reporting system that will be used by both agencies, thus eliminating
duplication of effort.

The two interim final rules will be published in the Dec. 13 issue of the
Federal Register and will take effect on Feb. 7, 2003. Each department will
accept public comments on the new rules for 60 days, and those comments
could result in regulatory changes in the future

The new rules are in accordance with the USA PATRIOT Act and the
Public Health Security and Bioterrorism Preparedness and Response Act of
2002. The USA PATRIOT Act sets requirements for the appropriate
use of select biological agents. It also specifies those persons who should
be restricted from working with select agents, and imposes criminal and
civil penalties for the inappropriate use of select agents. The Public
Health Security Bioterrorism Preparedness and Response Act of 2002
updated the existing Select Agent Rule by requiring facilities to
register if they possess select agents. Previously, only facilities that
wished to transfer select agents needed to register with CDC.

In an effort to educate interested parties about its new rule, HHS will
host a public forum on Possession, Use, and Transfer of Select Agents and
Toxins on December 16, 2002, 9 a.m. to 12 p.m. and 1:30 p.m. to 4 p.m. at
the Wilbur J. Cohen Building/Voice of America Building in the Cohen
Auditorium, 330 Independence Avenue SW Washington, D.C.

Note to Reporters: All HHS press releases, fact sheets and other press
materials are available at
http://www.hhs.gov/news. USDA news releases, program announcements and
media advisories are available on the Internet. Access the APHIS home page
by pointing your Web browser to
http://www.aphis.usda.gov and clicking on "APHIS Press Releases."

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